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Research compliance

Research and General Data Protection Regulations (GDPR)

Health and care research may be exploring prevention, diagnosis or treatment of disease, which includes health and social factors in any disease area.

All NHS organisations (including Health & Social Care in Northern Ireland) are expected to participate and support health and care research. The Health Research Authority (HRA) and government departments in Northern Ireland, Scotland and Wales set standards for NHS organisations to make sure they protect your privacy and comply with the law when they are involved in research. In addition, research ethics committees review research studies to make sure that the research uses of data about you are in the public interest, and meet ethical standards.

For information about how the Trust will collect and process your data for research purposes, plus the legal basis for collecting and using your information for research, please read here.

Managing Your Information - A Guide for Research Participants

The Health Research Authority has also produced guidance for the use of data for Research Purposes.


Information about Research Studies and Data

As an NHS organisation we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research.  This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.


If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).

Our Data Protection Officer is Richard Green and you can contact them at


Research may be sponsored by companies developing new medicines or medical devices, NHS organisations, universities or medical research charities. The Research Sponsor (the Data Controller) decides what information will be collected for the study and how it will be used.

Below is a list of current (Either recruiting new participants or in follow-up) Research Studies for which Norfolk and Suffolk NHS Foundation Trust is the Research Sponsor and Data Controller (Please click on study names for link to the HRA web record).


Name of Research StudyTitle of studyReference Number
BEST​BEST for adolescent BPD (Brief Education Supported Treatment for adolescent Borderline Personality Disorder): a feasibility study of delivery of specialised early intervention for borderline personality disorder through collaboration with education providers, incorporating a feasibility randomised controlled trial'.​250938
TRACCThe demenTia Research And Care Clinic (TRACC)205788
iCARE wp1Towards Integrated support: The role of carer- and patient-level characteristics on family CARER quality of life at different stages of dementia (iCARE)225765


Research Studies (Either recruiting new participants or in follow-up) for which NSFT is not the Research Sponsor/Data Controller but where NSFT Data is being directly or indirectly processed and shared for Research Purposes can be found below. 

To find out more about how your Data is being used in these studies, please contact the relevant Organisation listed in the below documents.

Non-NSFT Sponsored Research Studies (Aug 2020)

List of Educational Studies (Aug 2019)

NSFT Research policies
At NSFT Research, we have developed the following policies about setting up and conducting clinical research in the Trust.

Policies are in PDF format, and contain templates for use by researchers. Editable version of templates are also available from  Further guidance about conducting research in practice is available on the Researcher section of the website. 


SOP # Short Title Date Approved Published Download

Confirming research Capacity and Capability

24/11/2016 01/01/2017



R&D003 Research Integrity, Fraud and Misconduct 29/06/2017 01/07/2017


R&D005 Conducting Clinical Trials of Investigational Medicinal Products 26/06/2017 01/07/2017


R&D008 Research Trial Management: Trial Master Files and Site-Specific Files 27/04/2017 01/05/2017


R&D009 Research Auditing and Monitoring Procedures 27/04/2017 01/05/2017

RD009      ​

R&D012 Gaining Valid Informed Consent from Participants for the Purpose of Research Studies 28/06/2018 01/07/18

RD012 ​

R&D013 Research Study Close-down and Archiving Procedures 28/06/2018 28/06/2018


R&D016 v2.2 Research Adverse Event and Safety Reporting Procedures

28/06/2018 01/07/2018



SAE Form:

R&D029 Income Distribution from NIHR Adopted Industry Sponsored Studies 27/10/2016 01/11/2016


NSFT Research Operating Capability Statement
NSFT Research has an R&D Operational Capability Statement, endorsed by the Trust Board of Directors, which outlines our organisational capacity to undertake research:

NIHR B01 RnD Ops Capability May 2011


NIHR PID Reporting Data
The Government wishes to see a dramatic and sustained improvement in the performance of providers of NHS services in initiating and delivering clinical trials. In 2013 the NIHR requested that providers of NHS services publish outcomes of clinical trial research against certain benchmarks. From October 2014, the NIHR funding to providers of NHS services became conditional on the reporting of and meeting the two benchmarks of:

  • Recruiting the first patient within the 70 day time period from submission of the study

  • Delivery against the recruitment target agreed for the NSFT site.

The performance below reflects studies which are considered to be interventional or clinical trials only.

Performance in Initiating: Clinical Trials

Performance in Initiating Q2 2019-2020

Performance in Initiating Q3 2019-2020

Performance in Initiating Q4 2019-2020

Performance in Initiating Q1 2020-2021

Performance in Initiating Q2 2020-2021

Performance in Delivering: Commercial Studies

Performance in Delivering Q2 2019-2020

Performance in Delivering Q3 2019-2020

Performance in Delivering Q4 2019-2020

Performance in Delivering Q1 2020-2021

Performance in Delivering Q2 2020-2021

Previous PID Reports

National Research Guidance, Frameworks and Policies [Links to non-NSFT Controlled External Websites] 

European directive for Clinical Trial Regulations:

UK Clinical Trial Regulations

An Introduction to the UK Clinical Trial regulations

UK legislation​

UK Policy Framework for Health and Social Care Research​

Approving research under MCA section 34

MRC ethics guides


Informed Consent for Adults lacking capacity​